Degenerative Arthritis, Osteoarthritis
Conditions
Keywords
knee, osteoarthritis, joint, replacement, knee surgery
Brief summary
The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.
Interventions
DEVICEVanguard Knee System with AS Bearing
FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.
DEVICEVanguard Knee System with PS Bearing
FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
are identical to the indications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222. These indications are stated below: * Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * Correction of varus, valgus, or posttraumatic deformity. * Correction or revision of unsuccessful osteotomy, or arthrodesis. Patient selection factors to be considered include: * Need to obtain pain relief and improve function * Ability and willingness of the patient to follow instructions, including control of weight and activity level * A good nutritional state of the patient * The patient must have reached full skeletal maturity
Exclusion criteria
will be identical to the contraindications stated in the FDA approved labeling for the device 510(k) K023546, K033489, and K050222. These contraindications are stated below: -Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement. Relative contraindications include: * Uncooperative patient or patient with neurologic disorders who are incapable of following directions * Osteoporosis, * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may spread to the implant site, * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, * Vascular insufficiency, muscular atrophy, neuromuscular disease, * Incomplete or deficient soft tissue surrounding the knee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Knee Score | 1 Year Post-op | Average objective knee score; includes a combination of range of motion and pain scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | 3 Years | Average total knee score. Includes the objective and functional aspects of the knee score. |
| Dislocation | 3 Years | Rate of Dislocation as reported by patients in a complication. |
| Survivorship | 3 Years | Reports surivival of implant. |
| Reports of Radiographic Loosening via Complication Form | 3 Years | A more specific survivorship element; will indicate rate of loosening if it occurs. |
Outcome results
None listed